Patient Blood Management Certification Review Process Guide 2022

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Patient Blood Management Certification Review Process Guide 2022
Patient Blood Management
Certification
Review Process Guide
2022
Patient Blood Management Certification Review Process Guide 2022
Patient Blood Management
     Certification Program

          Review Process Guide

                         2022
What's New in 2022

Updates effective in 2022 are identified by underlined text in the activities noted below.

Changes effective January 1, 2022

Appendix A – Added a new summary graphic that displays the PBM Activity Level
requirements.

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TABLE OF CONTENTS

PATIENT BLOOD MANAGEMENT CERTIFICATION OVERVIEW ................................ 5

ORGANIZATION REVIEW PREPARATION ................................................................... 6

CERTIFICATION REVIEW NOTIFICATION AND POSTPONEMENT POLICIES .......... 9

REVIEWER ARRIVAL ................................................................................................... 10

OPENING CONFERENCE ............................................................................................ 11

ORIENTATION TO THE PATIENT BLOOD MANAGEMENT PROGRAM .................... 13

SYSTEM TRACER – DATA USE SESSION ................................................................. 15

REVIEWER PLANNING SESSION ............................................................................... 16

INDIVIDUAL TRACER ACTIVITY ................................................................................. 19

COMPETENCE ASSESSMENT AND CREDENTIALING SESSION ............................ 22

ISSUE RESOLUTION ................................................................................................... 24

REVIEWER REPORT PREPARATION......................................................................... 25

PROGRAM EXIT CONFERENCE ................................................................................. 26

SAMPLE AGENDA (1 REVIEWER, 1 DAY) .................................................................. 27

SAMPLE AGENDA (2 REVIEWERS, 1 DAY) ............................................................... 30

APPENDIX A – GUIDANCE TO PROGRAM ACTIVITY LEVELS ................................. 33

APPENDIX B – FREQUENTLY ASKED QUESTIONS (FAQS) .................................... 53

APPENDIX C – ADDITIONAL GUIDANCE FOR PERIOPERATIVE SERVICES .......... 60

APPENDIX D – ADDITIONAL RESOURCES ............................................................... 66

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Patient Blood Management Certification
Overview
Patient Blood Management (PBM) is an evidence-based, multidisciplinary approach to
optimizing care of patients who might need transfusion. It encompasses all aspects of patient
evaluation and clinical management surrounding the transfusion decision-making process,
including the application of appropriate indications, as well as minimization of blood loss and
optimization of patient red cell mass.

The Patient Blood Management certification program is a collaborative effort between AABB
and The Joint Commission. The AABB-Joint Commission Patient Blood Management
Certification promotes patient safety and quality and will help hospitals realize the maximum
benefits of establishing a comprehensive patient blood management program. This voluntary
hospital certification is based on the AABB Standards for a Patient Blood Management
Program.

The goals for certified organizations include the following:
•   Risk reduction in fewer adverse events and incidents
•   Improved patient outcomes
•   Reduced hospital stays, readmissions, and lengths of stay
•   Ensuring blood availability for those most in need
•   Optimized care for those who may need transfusion
•   Fostering collaboration throughout the hospital
•   Providing a competitive edge in the marketplace
•   Enhanced staff recruitment and development
•   Cost savings

The on-site certification review will be conducted by one or two reviewers, based on whether the
organization is accredited by AABB for Blood Banks and Transfusion Services. For
organizations that are AABB-accredited for Blood Banks and Transfusion Services, a Joint
Commission surveyor will perform a one-day review. Organizations that are not AABB-
accredited for Blood Banks and Transfusion Services will be evaluated by two reviewers (one
Joint Commission surveyor and one AABB assessor) for a one-day review.

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Organization Review Preparation
The Patient Blood Management Certification Review Process Guide describes each activity of
the Joint Commission on-site certification review. Organizations should read each of the
following activity descriptions, which include:
•   The purpose of the activity
•   Descriptions of what will happen during the activity
•   Discussion topics, if applicable
•   Recommended participants
•   Any materials required for the session

Share these descriptions organization-wide, as appropriate.

Pre-Review Phone Call
A Joint Commission account executive will contact your organization by phone shortly after
receiving your application for certification. The purpose of this call is to:
•   Confirm information reported in the application for certification,
•   Verify travel planning information and directions to main location for review,
•   Confirm your access to The Joint Commission Connect extranet site and the certification-
    related information available there (on-site visit agenda, Certification Review Process Guide,
    etc.), and
•   Answer any organization questions and address any concerns.

Logistics
• While on-site, the reviewer will need workspace for the duration of the visit. A desk or table,
   telephone, access to an electrical outlet and the internet are desirable.
•   Some review activities will require a room or area that will accommodate a group of
    participants. Group activity participants should be limited, if possible, to key individuals that
    can provide insight on the topic of discussion. Participant selection is left to the
    organization’s discretion; however, this guide does offer suggestions.
•   The reviewer will want to move throughout the hospital and blood bank during Individual
    Tracer Activity, talking with staff and observing the day-to-day operations of the organization
    along the way. The reviewer will rely on organization staff to find locations where
    discussions can take place that allow for confidentiality and privacy, and that will minimize
    disruption to areas being visited.
•   While the reviewer will focus on current patients that are included in the patient blood
    management program, they may request to see some closed records as well in order to
    verify compliance with the Patient Blood Management Certification requirements.

The sample agenda for the on-site review appears later in this guide, and will be posted to your
Joint Commission Connect extranet site. The review agenda presents a suggested order and
duration of activities. Prior to the review date, please discuss the agenda and activities with the

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Account Executive. When the reviewer arrives, discuss any agenda changes during the on-site
visit.

Documentation Requested from the Program
Although the majority of documentation review will occur as part of individual tracer activity, it is
helpful to have the references and resources staff use in their day-to-day activities available.

The reviewer may request the following items to assist in patient tracer selection during the
Reviewer Planning session:
•   Current list of patients receiving blood transfusions or who may likely receive a blood
    transfusion (see suggested tracer patient list)
•   If there are a limited number of admissions, a list of discharged patients who received blood
    transfusions
        This request can go back as far as the past four months for initial reviews
•   Performance improvement action plans that demonstrate how data have been used to
    improve program care and services, when available
•   The reviewer may also request the following documents:
        Organizational chart with hierarchy of responsibilities to the program
        Executive management roles and responsibilities
        Interdisciplinary team qualifications, job descriptions, training, and competency
        Patient-centered quality plan
        Emergency management plan and communication system
        Equipment maintenance and information management records
        Supplier evaluations and contract agreements
        Policies and procedures for patient blood management
        Patient information regarding blood transfusion, blood management
        Educational materials given to patient/family
        Record retention policies
        Information management procedures and records
        Procedures for deviations, nonconformances, and adverse events
        Program assessments and performance improvement

Preparing for Patient Tracer Selection
Organizations are encouraged to begin identifying patients for individual tracer activity in
advance of the review date. The reviewer will still be involved in the selection of the specific
patients, but it will ease the pressure and burden on staff in trying to find the types of patients
that the reviewers want to trace. Availability of this information will greatly facilitate the
Reviewer Planning session and allow the individual tracer activity to proceed in a timely manner.

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If there are a limited number of active patients at the time of the on-site review, or the active
patients do not meet all of the selection criteria, closed records may be reviewed to observe the
program’s interaction with as much of the target population as possible.

Depending on the services provided by the organization, suggested tracer patients may include:
•   Patients receiving a massive transfusion
•   Patients receiving regular transfusions
•   Patients that decline blood products or transfusions
•   Patients with chronic anemia
•   Patients receiving stem cell transplants
•   Patients with elective surgery (preoperative, postoperative)
•   Patients from the intensive care, pediatrics, obstetrics, or oncology departments

Preparing for Competence Assessment and Credentialing
As the process to obtain personnel and credentials files may be time-consuming, particularly if
files are stored off-site, organizations may consider identifying files to request in advance of the
on-site review to facilitate the organization’s retrieval efforts. The reviewer will still be involved
in the selection of personnel files to review, but the availability of this information will allow the
Competence Assessment and Credentialing session to proceed in a timely manner.

Suggested personnel files to request may include:
•   PBM medical director
•   PBM coordinator
•   Midlevel practitioner that orders blood
•   Medical technologist in the blood bank
•   Perfusionist
•   RN from the ICU, ER, or OR
•   Anesthesiologist

Questions
Questions about the Patient Blood Management certification standards and elements of
performance:
•   Contact AABB at standards@aabb.org.

Questions about on-site review process, agenda, scheduling, or other questions:
•   Call your Joint Commission Account Executive.

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Certification Review Notification and
Postponement Policies

Notice of Initial Certification On-site Review
If this is your program’s first time through the certification process you will receive a thirty (30)
day advance notice of your on-site review date(s). Notice will be provided via e-mail to the
individuals identified on your account as the Primary Certification Contact and CEO. Also, thirty
(30) days prior to your review, the Notification of Scheduled Events section on your
organization’s extranet site, The Joint Commission Connect, is populated with the event along
with a link to the reviewer(s) name, biographical sketch and photograph.

Notice of Re-Certification On-site Review
Your organization will receive notice from The Joint Commission seven (7) business days prior
to the first day of the scheduled review date(s) for Patient Blood Management re-certification.
The notice will be emailed to the individuals identified on your account as the Primary
Certification Contact and CEO and will include the specific review date(s) and the program(s)
being reviewed. Additionally, at 7:30 a.m. in your local time zone on the morning of the review,
the Notification of Scheduled Events section on your organization’s extranet site, The Joint
Commission Connect, is populated with the review event including a link to the reviewer(s)
name, biographical sketch and photograph.

Review Postponement Policy
The Joint Commission may not certify a program if the Organization does not allow The Joint
Commission to conduct a review. In rare circumstances, it may be appropriate to request a
review postponement. An organization should direct a request for postponement to its Account
Executive. A request to postpone a review may be granted if a major, unforeseen event has
occurred that has totally or substantially disrupted operations, such as the following:

    •    A natural disaster or major disruption of service due to a facility failure
    •    The organization’s involvement in an employment strike
    •    The organization’s cessation of admitting or treating patients
    •    The organization’s inability to treat and care for patients and its transference of patients
         to other facilities

The Joint Commission may, at its discretion, approve a request to postpone a review for an
organization not meeting any of the criteria listed above.

Your organization’s Certification Account Executive can answer questions about these policies
or put you in contact with other Joint Commission staff that can assist you.

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Reviewer Arrival

Logistics

Duration
10 minutes

Participants
•   Reception, Security, or Information Desk Staff
•   Organization/Program Contact

Procedures

1. The reviewer will arrive at the location identified as the main or primary site between 7:45
   and 7:50 a.m.
2. The reviewer will report to the reception area, security officer, information desk, or
   administrative office upon arrival and provide the reviewer’s name, identification and
   purpose for the visit.
3. If a program contact is not waiting for the reviewer, the reviewer will ask security or reception
   to phone the program contact. The reviewer will wait for an escort unless instructed to
   proceed to another location by the organization/program contact.
4. The reviewer will follow organization visitor procedures as instructed by security or the
   program contact (e.g. sign in, wear organization visitor identification).
5. While this is an announced visit, the reviewer will still confirm that the organization/program
   contact has been able to access their extranet site and locate information about the review,
   including
    •    Notification of scheduled Joint Commission event authorizing your presence
    •    Reviewer name, picture and biographical sketch
    •    Scheduled review date
6. Please inform the reviewer about
    •    Working space for the day
    •    A secure location to place belongings and access them as needed throughout the day
7. Inform the reviewer if there will be a roster of patient blood management program leaders
   and staff attending the Opening and Orientation activities or if attendees will sign in. A
   roster or sign in sheet with the names of staff encountered and their roles in the program
   can be helpful with the review process.
8. Plan to leave at least 15 minutes of the opening conference to review the visit agenda and
   for questions and answers.

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Opening Conference

Logistics

Objectives
1. Introductions of program representatives and reviewer(s)
2. Describe the structure of the review
3. Discuss the review agenda, highlighting any changes necessary to facilitate the site visits or
   increase participation in group activities
4. Answer any open questions about the visit or review process

Duration
10 minutes

Participants
Program administrative and clinical leadership and others at the discretion of the organization

Other Information
If available, the following items are helpful to the reviewer:
•   Roster or sign-in sheet of participants
•   Organization chart or names of program leadership, titles and roles

Procedures

During
The reviewer will:
•   Provide a brief self-introduction including background and relevant experience.
•   Explain the purpose of the certification review.
•   Ask organization attendees to introduce themselves.
•   Describe each component of the review agenda, discuss the plans for tracer activity,
    potential tracer patients, and areas to visit. Make changes to the schedule if necessary.
•   Explain that the majority of review activity occurs at the point where care, treatment and
    services are provided. The term “Individual Tracer” denotes the review method used to
    evaluate organization/program compliance with standards.
•   Remind the program that they want to be as least disruptive to patient care as possible.
    They will suggest that the program limit the number of staff accompanying them on tracer
    activity to three or less.

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•   Introduce the new SAFER™ matrix feature of the Summary of Certification Review Findings
    Report.
•   Mention the changes to the post-review Clarification process.
•   Ask if there are any questions about the review.
•   Answer questions and encourage representatives to ask questions throughout the review.

After
The reviewer will transition into the Orientation to the Patient Blood Management Program
session.

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Orientation to the Patient Blood
Management Program

Logistics

Objectives
Become familiar with the patient blood management program, including:
1. An understanding of the patient blood management program philosophy and approach
2. A better understanding of the patient blood management program structure and scope
3. How well integrated the program is throughout the organization

Duration
50 minutes

Participants
Program administrative and clinical leadership and others at the discretion of the organization

Notes
Materials that may prove useful for this session:
•   Organization chart for the program, if available
•   Copies of slides, if the program is making a formal presentation

Procedures

During
If a presentation is planned, the reviewer will ask the presenter to indicate if they would like to
take questions during or at the conclusion.

The organization is asked to provide a high-level overview of their patient blood management
program through either a formal presentation or in discussion with reviewer. The focus should
be on the following:
•   Program scope
•   Program mission, goals and objectives
•   Program structure and relationship to the organization structure
•   Program leadership and executive management responsibilities
•   Interdisciplinary team members, including roles and responsibilities
•   Organizational supports for the patient blood management program

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•   Development and implementation of the program (e.g. timeline, successes and
    opportunities, challenges and barriers)
•   Patient blood management program activities
•   Identify the program level designation
•   Any unique program communication regarding patient rights and responsibilities and their
    right of refusal of care, treatment, and services offered
•   Assessing practitioner and staff competence in patient blood management
•   Organizational support for patient blood management program practitioners and staff
    education and specialized training
•   Processes supporting credentialing, privileging, and licensure/ registration/certification,
    education and experience verifications
•   Evaluating and improving the program’s performance

After
Determine if there are additional documents the reviewer would like to see as a result of the
orientation discussions.

The reviewer will transition to the System Tracer – Data Use session for a more in-depth
discussion regarding how the program is using data to evaluate and improve the program’s
performance.

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System Tracer – Data Use Session
Logistics

Objectives
1. To learn how the patient blood management program is using data to evaluate the safety
   and quality of care provided to patients
2. To understand and assess the program’s performance improvement process

Duration
30 minutes

Participants
Program leaders, clinical leaders, and others at the discretion of the program

Data Requirements
•   For initial certification, the organization should provide four months of data
•   For recertification, the organization should provide twelve months of data

Procedures

During
During this activity, the reviewer and organization will discuss:
•   Program performance measurement and improvement activities
        Performance improvement plan review including priority setting
        Data collection and data quality monitoring
        Data analysis and dissemination
•   Program data available for, and used in decision-making
•   Program evaluation by leaders and staff
•   Recently implemented program improvement
•   Ongoing performance monitoring
•   Taking actions to improve

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Reviewer Planning Session

Logistics

Duration
30 minutes

Participants
Program contact or staff, if requested by the reviewers

Procedures

Before
•   Explain to the organization the purpose of this session
•   Make sure all necessary documents are available, especially patient lists.

During
The reviewer will:
•   Describe to program representatives the types of patients they want to trace and request
    assistance in identifying individuals that fit the description. Tracer selection should include
    representation of the target population(s).
    Note: This may or may not be possible to accomplish using a list of active patients. The
    reviewer and program representative may need to proceed directly to a patient care unit and
    ask the staff to help identify patients.

•   Select a minimum of five (5) tracer patients
        Patients selected should present the opportunity to trace care, treatment and services
         through as many of the potential departments, areas, sites or services that support or
         participate directly in the patient blood management program or support the work of the
         program in any unique way.
        Patients should have different characteristics, such as demographics, age, sex, or
         situations or other factors that would influence patient care.
        As blood bank/transfusion services and perioperative services are integral to the patient
         blood management program, a tracer patient that will incorporate a visit to the blood
         bank and interaction with staff from perioperative services will be selected.

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•   Suggested tracer patients may include:
        Patients receiving a massive transfusion
        Patients receiving regular transfusions
        Patients that decline blood products or transfusions
        Patients with chronic anemia
        Patients receiving stem cell transplants
        Patients with elective surgery (preoperative, postoperative)
        Patients from the intensive care, pediatrics, obstetrics, or oncology departments
•   If there are a limited number of active patients at the time of the on-site review, or the active
    patients do not meet all of the selection criteria, closed records will be reviewed to observe
    the program’s interaction with as much of the target population as possible.
•   As the process to obtain personnel and credentials files may be time-consuming, particularly
    if files are stored off-site, the reviewer may begin requesting files earlier in the day to
    facilitate the organization’s retrieval efforts. Program staff should inform the reviewer of how
    much time is needed to retrieve personnel and credentials files.
•   Select a minimum of five (5) personnel files to review, which may include:
        PBM medical director
        PBM coordinator
        Midlevel practitioner that orders blood
        Medical technologist in the blood bank
        Perfusionist
        RN from the ICU, ER, or OR
        Anesthesiologist
        Additional files may be requested during tracer activity

Documentation Requested from the Program
The program is requested to provide the following items to the reviewer to assist in patient
tracer selection.

•   Current list of patients receiving blood transfusions or who may likely receive a blood
    transfusion (see suggested tracer patient list)
•   If there are a limited number of admissions, a list of discharged patients who received blood
    transfusions
        This request can go back as far as the past four months for initial reviews
•   Performance improvement action plans that demonstrate how data have been used to
    improve program care and services, when available

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•   The reviewer may also request the following documents:
        Organizational chart with hierarchy of responsibilities to the program
        Executive management roles and responsibilities
        Interdisciplinary team qualifications, job descriptions, training, and competency
        Patient-centered quality plan
        Emergency management plan and communication system
        Equipment maintenance and information management records
        Supplier evaluations and contract agreements
        Policies and procedures for patient blood management
        Patient information regarding blood transfusion, blood management
        Educational materials given to patient/family
        Record retention policies
        Information management procedures and records
        Procedures for deviations, nonconformances, and adverse events
        Program assessments and performance improvement

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Individual Tracer Activity

Logistics

Objectives
1. Follow a patient’s care, treatment, and services to confirm the program’s compliance with
   the patient blood management certification requirements.
2. Evaluate the program’s design and implementation of processes that facilitate the
   integration of patient blood management across the organization.

Duration
Variable per patient tracer conducted; tracing of multiple patients in multiple locations occurs
during the blocks of time noted on the agenda

Participants
Staff, program representatives and management who have been involved in an individual’s
care, treatment, or services.

The reviewer will require an escort during each of the blocks of tracer time.

Procedures
A significant portion of the agenda is designated to patient tracer activity. The number of
patients traced during this time will vary. Tracer activity begins on the inpatient unit where the
patient is receiving care, treatment and services, or in the case of a discharged patient, the
location from which they were discharged.

During
•   The reviewer will use the patient’s record to discuss and map out the patient’s course of
    care, treatment and services. The number of staff participating in this stage of the tracer
    should be limited.
•   The reviewer will follow the map, moving through the organization, as appropriate, visiting
    and speaking with staff in all the areas, programs, and services involved in the patient’s
    encounter. There is no mandated order for visits to these other areas. Reviewers will speak
    with any staff available in the area.
•   Throughout tracer activity, the reviewer will:
     Observe program staff and patient interaction
     Interview staff about the care, treatment and services they provide and their knowledge
       of the patient blood management program
     Interview patients or families, if appropriate and permission is granted by the patient or
       family
     Review policies, processes, and procedures for patient blood management
     Discuss equipment maintenance and quality control issues
     Inquire about the processes for document control and record retention
     Observe environmental conditions

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Blood Bank/Transfusion Services:
• For organizations that ARE accredited by AABB for Blood Banks and Transfusion Services,
   the reviewer will:
        Confirm that equipment controlled by the blood bank or transfusion service is controlled
         in accordance with the manufacturer’s instructions and/or the current edition of AABB
         Standards for Blood Banks and Transfusion Services.
        Verify that pretransfusion testing policies are consistent with the current edition of AABB
         Standards for Blood Banks and Transfusion Services.
        Confirm that documents and records related to transfusion medicine are created and
         controlled in accordance with the current edition of the AABB Standards for Blood Banks
         and Transfusion Services or the requirements of an equivalent accrediting body.
        Discuss the process to ensure that all deviations, nonconformances, and adverse events
         related to blood transfusion are managed in accordance with the current editions of
         AABB Standards for Blood Banks and Transfusion Services or the requirements of an
         equivalent accrediting body.

•   For organizations that ARE NOT accredited by AABB for Blood Banks and Transfusion
    Services (see Appendix B for additional guidance), the reviewer will:
        Identify the process to make sure equipment controlled by the blood bank or transfusion
         service is controlled in accordance with the manufacturer’s instructions and/or the
         current edition of AABB Standards for Blood Banks and Transfusion Services.
        Review pretransfusion testing policies to make sure they are consistent with the current
         edition of AABB Standards for Blood Banks and Transfusion Services.
        Ask staff how documents and records related to transfusion medicine are created and
         controlled in accordance with the current edition of the AABB Standards for Blood Banks
         and Transfusion Services or the requirements of an equivalent accrediting body.
        Discuss the process to ensure that all deviations, nonconformances, and adverse events
         related to blood transfusion are managed in accordance with the current editions of
         AABB Standards for Blood Banks and Transfusion Services or the requirements of an
         equivalent accrediting body.

Perioperative Services (see Appendix C for additional guidance):
• The reviewer will:
        Confirm that equipment controlled by the perioperative program is controlled in
         accordance with the manufacturer’s instructions and/or the current edition of AABB
         Standards for Perioperative Autologous Blood Collection and Administration.
        Verify that document and records related to the perioperative program are created and
         controlled in accordance with the current edition of the AABB Standards for
         Perioperative Autologous Blood Collection and Administration or the requirements of an
         equivalent accrediting body.
        Discuss the process to ensure that all deviations, nonconformances, and adverse events
         related to blood transfusion are managed in accordance with the current edition of AABB

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Standards for Perioperative Autologous Blood Collection and Administration or the
         requirements of an equivalent accrediting body.
•   For Program Activity Level 1 organizations:
        If the perioperative program is already accredited by AABB, this requirement has been
         satisfied.
        If the perioperative program is not accredited by AABB, the reviewer will confirm that the
         AABB requirements for cell salvage or processing of perioperative blood products (e.g.,
         platelet gel, platelet-rich plasma) are met in accordance with the AABB Standards for
         Perioperative Autologous Blood Collection and Administration.

After
•   As necessary, pull additional records to verify standards compliance issues identified during
    the Individual Tracer.
•   As necessary, request other documentation to confirm procedures and validate practice.

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Competence Assessment and Credentialing
Session

Logistics

Objectives
1. Learn more about the organization’s competence assessment process for program staff,
   licensed independent practitioners, and other credentialed practitioners.
2. Learn more about the organization’s orientation, education, and training processes as they
   relate to program staff, licensed independent practitioners, and other credentialed
   practitioners encountered during Individual Tracers.
3. Identify competence assessment process-related strengths and potential risk points.

Duration
30 minutes

Participants
Individuals responsible for:
•   Aspects of the organization’s human resources processes that support the patient blood
    management program
•   Orientation and education of program staff
•   Assessing program staff competency
•   Assessing program's licensed independent practitioners and other credentialed practitioners'
    competency, when applicable.

Procedures

During
•   The reviewer will participate in a facilitated review of selected files, based on the patient
    blood management program team and individuals encountered during tracer activity
•   Files stored off-site may not need to be reviewed as long as the local files include the
    following information:
        Job descriptions for all program staff, licensed independent practitioners, and other
         credentialed practitioners
        Experience, education, and abilities assessments for program staff and licensed
         independent practitioners

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    Information on orientation for staff, licensed independent practitioners, and other
         credentialed practitioners to the organization, to the program, to job responsibilities,
         and/or clinical responsibilities
        Ongoing education and training for program staff and licensed independent practitioners
        Competency assessment for program staff
        Facility-defined education for individuals that order and transfuse blood

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Issue Resolution

Logistics

Objectives
1. Obtain any additional information or documentation required to resolve issues identified
   during the review.
2. Follow-up on potential findings that could not be resolved in other on-site activities.

Duration
15-30 minutes

Participants
As requested by the reviewer, depending on the issue(s) to be discussed

Procedures

During
•   The reviewer may have identified issues during individual tracer activity or other sessions
    that require further exploration or follow-up with staff.
•   This follow-up may include a variety of activities such as:
        Review of policies and procedures
        Additional patient records, or components of records, to confirm an Individual Tracer
         finding
        Review of personnel or credentials files and facility-defined educational requirements
        Review of performance improvement data
        Discussions with selected staff

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Reviewer Report Preparation

Logistics

Objectives
1. Complete the entry of observations made throughout the survey
2. Prepare an event summary to share with the program

Duration
45-60 minutes

Participants
Program participation is not required

Procedures
The reviewer will:
•   Analyze observations and determine if there are any findings that reflect standards
    compliance issues.
•   Make arrangements with the program representatives to print and copy the report for:
        The organization, if it is being distributed to Program Exit Conference participants
        Each reviewer
•   Inform the program contact that they are ready to proceed with the Program Exit Conference

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Program Exit Conference

Logistics

Objectives
1. Present the Summary of Certification Review Findings Report (only if desired by the CEO)
2. Review identified standards compliance issues and note that all findings of less than full
   compliance require resolution through an Evidence of Standards Compliance submission
3. Review required follow-up actions

Duration
30 minutes

Participants
•   Program and clinical leaders
•   Other staff at the discretion of the organization

Procedures

During
•   The reviewer will share a report of their on-site experience and observations.
•   The reviewer will highlight strengths and progress and will note any potential areas of
    vulnerability and how these relate to the standards and what the program will see reflected
    in the Summary of Certification Review Findings. The reviewer will also present the newest
    feature of the Summary report, the SAFER™ matrix, and will discuss the display of
    Requirements for Improvement, if any, and the significance of their placement.
•   The reviewer will not go through the report item by item with the group assembled for the
    Program Exit Conference. If the organization desires this level of report discussion, it is
    recommended that it occur with just a small number of program representatives.
•   The reviewer will mention changes to the post-review Clarification process and note any
    impact these have on the organizations certification review follow-up actions.

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Sample Agenda (1 Reviewer, 1 Day)
                          Patient Blood Management Certification

      For use in organizations accredited by AABB for Blood Banks and Transfusion Services

                                                                                              Suggested
       Time                                 Activity & Topics                                Organization
                                                                                              Participants
 8:00 – 8:10           Opening Conference                                              -   Program
                       - Introductions                                                     administrative and
                       - Brief review of agenda                                            clinical leadership
                                                                                       -   Others at program’s
                                                                                           discretion

 8:10 – 9:00           Orientation to the Program                                      -   Program
                       - Program scope                                                     administrative and
                       - Program mission, goals and objectives                             clinical leadership
                       - Program structure, and program relationship to the            -   Others at program’s
                           organization structure                                          discretion
                       - Program leadership and executive management
                           responsibilities
                       - Interdisciplinary team members, including roles and
                           responsibilities
                       - Organizational supports for the patient blood
                           management program
                       - Development and implementation of the program (e.g.
                           timeline, successes and opportunities, challenges and
                           barriers)
                       - Patient blood management program activities
                       - Identify the program level designation
                       - Any unique program communication regarding patient
                           rights and responsibilities and their right of refusal of
                           care, treatment, and services offered
                       - Assessing practitioner and staff competence in patient
                           blood management
                       - Organizational support for patient blood management
                           program practitioners and staff education and
                           specialized training
                       - Processes supporting credentialing, privileging, and
                           licensure/ registration/certification, education and
                           experience verifications
                       - Evaluating and improving the program’s performance

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Suggested
       Time                                 Activity & Topics                                Organization
                                                                                              Participants
 9:00 – 9:30           System Tracer – Data Use                                        -   Program leaders,
                       - Program performance measurement and improvement                   clinical leaders
                          activities                                                   -   Others at program’s
                           Performance improvement plan review including                  discretion
                              priority setting
                           Data collection and data quality monitoring
                           Data analysis and dissemination
                       - Program data available for, and used in decision-
                          making
                       - Program evaluation by leaders and staff
                       - Recently implemented program improvement

 9:30 – 10:00          Reviewer Planning Session                                       -   Organization’s
                       - Individual patient tracer selection                               review coordinator
                       - Personnel and credentials files

                       Note: Tracer selection requires a list, census report or
                       other summary of patients currently receiving blood
                       transfusions or who may likely receive a blood transfusion.

 10:00 – 12:00         Individual Tracer Activity                                      -   Staff, program
                       - Tracer activity begins where the patient is currently             representatives, and
                           receiving care, treatment and services                          management
                       - Interactive review of patient record(s) with team                 involved in the
                           member or organization staff actively working with the          patient’s care,
                           patient—map patient’s course of care, treatment and             treatment, or
                           services up to the present and anticipated for the future       services
                       - May include a patient and family interview, if they are
                           willing to participate

 12:00 – 12:30         Lunch
 12:30 – 2:30          Individual Tracer Activity – continued                          -   Staff, program
                       - Additional tracer activity                                        representatives, and
                       - Blood bank and perioperative services review                      management
                       - Note: Personnel and competency files for blood bank               involved in the
                           and perioperative staff will be reviewed at this time.          patient’s care,
                                                                                           treatment, or
                                                                                           services

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Suggested
       Time                                 Activity & Topics                                Organization
                                                                                             Participants
 2:30 – 3:00           Competence Assessment and Credentialing Process                 -   Individual with
                       - Discussion during this session will focus on:                     authorized access to
                           Processes for obtaining team member credentials                personnel and
                             information                                                   credentials files
                           Orientation and training process for program team          -   Individual familiar
                           Methods for assessing competence of practitioners              with program-
                             and team members                                              specific
                           In-service and other ongoing education activities              requirements for
                             available to program team members                             team members

                       Note: The reviewer will request personnel records and
                       credentials files to review based on team members and
                       staff encountered or referred to throughout the day.
                       Program staff should inform the reviewer of how much time
                       is needed to retrieve personnel and credentials files.

 3:00 – 4:00           Issue Resolution and Reviewer Report Preparation                -   As requested by
                                                                                           reviewer depending
                                                                                           on the issue
 4:00 – 4:30           Program Exit Conference                                         -   Program
                                                                                           administrative and
                                                                                           clinical leadership
                                                                                       -   Others at program’s
                                                                                           discretion

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Sample Agenda (2 Reviewers, 1 Day)
                          Patient Blood Management Certification
For use in organizations not accredited by AABB for Blood Banks and Transfusion Services

                                                                                              Suggested
       Time                                 Activity & Topics                                Organization
                                                                                              Participants
 8:00 – 8:10          Opening Conference                                               -   Program
                      - Introductions                                                      administrative and
                      - Brief review of agenda                                             clinical leadership
                                                                                       -   Others at program’s
                                                                                           discretion

 8:10 – 9:00          Orientation to the Program                                       -   Program
                      - Program scope                                                      administrative and
                      - Program mission, goals and objectives                              clinical leadership
                      - Program structure, and program relationship to the             -   Others at program’s
                          organization structure                                           discretion
                      - Program leadership and executive management
                          responsibilities
                      - Interdisciplinary team members, including roles and
                          responsibilities
                      - Organizational supports for the patient blood
                          management program
                      - Development and implementation of the program (e.g.
                          timeline, successes and opportunities, challenges and
                          barriers)
                      - Patient blood management program activities
                      - Identify the program level designation
                      - Any unique program communication regarding patient
                          rights and responsibilities and their right of refusal of
                          care, treatment, and services offered
                      - Assessing practitioner and staff competence in patient
                          blood management
                      - Organizational support for patient blood management
                          program practitioners and staff education and
                          specialized training
                      - Processes supporting credentialing, privileging, and
                          licensure/ registration/certification, education and
                          experience verifications
                      - Evaluating and improving the program’s performance

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Suggested
       Time                                 Activity & Topics                                Organization
                                                                                              Participants
 9:00 – 9:30          System Tracer – Data Use                                         -   Program leaders,
                      - Program performance measurement and improvement                    clinical leaders
                         activities                                                    -   Others at program’s
                          Performance improvement plan review including                   discretion
                             priority setting
                          Data collection and data quality monitoring
                          Data analysis and dissemination
                      - Program data available for, and used in decision-
                         making
                      - Program evaluation by leaders and staff
                      - Recently implemented program improvement

 9:30 – 10:00         Reviewer Planning Session                                        -   Organization’s
                      - Individual patient tracer selection                                review coordinator
                      - Personnel and credentials files

                      Note: Tracer selection requires a list, census report or other
                      summary of patients currently receiving blood transfusions
                      or who may likely receive a blood transfusion.

 10:00 – 12:00        Reviewer 1:                         Reviewer 2:                  -   Staff, program
                      Individual Tracer Activity          Blood Bank Review                representatives, and
                      - Tracer activity begins            - Equipment                      management
                          where the patient is            - Pretransfusion testing         involved in the
                          currently receiving care,       - Records                        patient’s care,
                          treatment and services          - Nonconformance                 treatment, or
                      - Interactive review of                                              services
                          patient record(s) with team
                          member or organization
                          staff actively working with
                          the patient—map patient’s
                          course of care, treatment
                          and services up to the
                          present and anticipated
                          for the future
                      - May include a patient and
                          family interview, if they are
                          willing to participate
 12:00 – 12:30        Lunch
 12:30 – 2:30         Reviewer 1:                         Reviewer 2:                  -   Staff, program
                      Individual Tracer Activity –        Perioperative Services           representatives, and
                      continued                           Review                           management
                      - Additional tracer activity        - Equipment                      involved in the
                                                          - Records                        patient’s care,
                                                          - Nonconformance                 treatment, or
                                                                                           services
 2:30 – 3:00          Competence Assessment and Credentialing Process                  -   Individual with
                      Discussion during this session will focus on:                        authorized access to
                      - Processes for obtaining team member credentials                    personnel and
                          information                                                      credentials files
                      - Orientation and training process for program team              -   Individual familiar
                                                                                           with program-

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Suggested
       Time                                 Activity & Topics                                Organization
                                                                                             Participants
                      -    Methods for assessing competence of practitioners and           specific
                           team members                                                    requirements for
                      -    In-service and other ongoing education activities               team members
                           available to program team members

                      Note: The reviewer will request personnel records and
                      credentials files to review based on team members and staff
                      encountered or referred to throughout the day. Program
                      staff should inform the reviewer of how much time is needed
                      to retrieve personnel and credentials files.

 3:00 – 4:00          Issue Resolution and Reviewer Report Preparation                 -   As requested by
                                                                                           reviewer depending
                                                                                           on the issue
 4:00 – 4:30          Program Exit Conference                                          -   Program
                                                                                           administrative and
                                                                                           clinical leadership
                                                                                       -   Others at program’s
                                                                                           discretion

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Appendix A – Guidance to Program Activity
Levels
Overview
The Patient Blood Management (PBM) Certification program is designed to evaluate
organizations with varying levels of complexity. The three program activity levels (Level 1, 2,
and 3) are based on the services and capabilities at each organization.
• A small hospital may have a clinical program and services that meet the program level
   activities described as Level 3.
•   A large hospital might have a clinical program and services that incorporates all the activities
    described for Level 1.
•   It should be recognized that one level is not superior to another and merely reflects
    differences in the activities performed by the hospital in which the PBM program resides.

Each organization that applies for Patient Blood Management Certification is required to
designate an activity level prior to the on-site review. The electronic application (E-App)
includes an Eligibility Requirements section that prompts the organization to select the
appropriate activity level for their PBM program.

Applicability of Standard PBMOR.4
During the on-site review, the PBM program will be evaluated for compliance with the
expectations that reflect their designated program activity level. The expectations for each
activity level are presented in Standard PBMOR.4, Elements of Performance (EPs) 2-24.
Standard PBMOR.4, EP 1 applies to all activity levels.

As each activity level addresses organizations with different capabilities, the PBM program’s
activity level will determine which EPs are applicable during the certification review:
•   Activity Level 1: EPs 2-24 are applicable
•   Activity Level 2: EPs 2-20 are applicable
•   Activity Level 3: EPs 2-17 are applicable

Additional Guidance
The following table provides examples of questions that can help determine whether a PBM
program has addressed all the applicable EPs. Although there may be some overlap between
the items on this list, taken as a whole, the activities described reflect the total scope of activities
performed by a PBM program.

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Standard PBMOR.4 – The executive management defines, oversees, and monitors the
activities of the program.

The program is responsible for, or has direct involvement with, oversight and monitoring
of the following activities:

                                                                              Activity   Activity    Activity
                        Element of Performance
                                                                              Level 1    Level 2     Level 3
 2. Evidence of institutional support for the patient blood                      X          X           X
    management program at the executive level.
    • Does the program have the full support of the medical
       director of the parent facility, including financial
       support and information technology (IT) support with
       specific IT staff to assist with implementing clinical
       workflows and data reporting?
    • Does the program have dedicated Transfusion Safety
       Officers or other individuals who are tasked with
       overseeing the PBM program?
    • Is there a direct liaison relationship between the PBM
       program and the executive management of the parent
       facility?

 3. Metrics regarding transfusion appropriateness in                               X        X              X
    accordance with transfusion guidelines.
    The PBM program must establish evidence-based
    metrics or key performance indicators to evaluate
    adherence to transfusion guidelines for every transfusion.
    The medical and nursing staff must have guidance on
    transfusion appropriateness criteria. This can be provided
    within order sets or built into the computer blood order
    entry system as clinical decision support or choices for
    mandatory entry fields.

      Outside of the order sets, this might also take the form of
      routine educational programs, in-service sessions, or
      posted information on the program-specific website.
      Reporting of the overall facility transfusion
      appropriateness rate and the rates for specific care areas
      would satisfy this item. Examples include:
      • Inpatient vs outpatient.
      • Extra- vs intraoperative care.
      • Medical vs surgical critical care.
      • Cardiology.
      • Hematology/oncology.
      • Obstetrics.
      • Orthopedics.

      It may useful to perform reporting at hierarchical levels
      (hospital-wide, by department, by surgical procedure, by
      physician, etc) and risk-adjustment methods can be used

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Activity   Activity    Activity
                        Element of Performance
                                                                              Level 1    Level 2     Level 3
      to facilitate comparisons between groups or physicians.
      Powerful tools for changing behavior and sustaining
      change include:
      • Reporting metrics such as “percentage >1-unit Red
          Blood Cell (RBC) transfusion orders.”
      • Reporting metrics such as “percentage RBC
          transfusion orders above hemoglobin threshold
          established by facility guidelines.”
      • Benchmarking the blood-ordering physicians with
          peer comparisons.
      • Providing surgeons and anesthesiologists with blood
          utilization peer comparisons (common surgical
          procedures or pretransfusion hemoglobin threshold vs
          posttransfusion hemoglobin target would also meet
          the intent of this requirement).

 4. Documentation of transfusion including patient                                 X        X              X
    consent, observation, adverse events, and outcomes.
    Documentation of the practices and processes associated
    with transfusion is imperative in a PBM program. This
    includes the entirety of the informed consent process,
    including consent for (or refusal of) transfusion, patient
    identification, patient and component correlation, the
    infusion procedure with vital signs monitoring, reporting of
    adverse reactions, and posttransfusion documentation of
    whether the transfusion had the intended effect.
      Laboratory-related documentation includes patient
      identification, proper sample labeling, reporting of sample
      labeling errors and process improvements, and any errors
      related to blood typing of patients and components that
      could result in mistransfusion.

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Activity   Activity    Activity
                        Element of Performance
                                                                              Level 1    Level 2     Level 3
      Budgeting to the level of care required by the                             X          X           X
      implementation of these PBM Standards.

      The PBM program should take into account the total cost
      of its program including personnel, equipment, reagents,
      supplies, other facility-specific program costs, as well as
      accreditation costs. To garner support and funding for
      maintaining operations, the PBM program should also
      take into account impact of the following:
      • The financial savings in terms of the acquisition cost
           of blood components not used.
      • Activity-based savings for transfusion procedures not
           performed.
      • Other potential cost savings related to better patient
           outcomes [eg, shorter length of stay, decreased
           intensive care unit (ICU) time, fewer infections, fewer
           re-operations, decreased kidney injuries, etc].

      The financial impact and cost savings of a PBM program
      can affect departments differently. For example, while the
      laboratory may see a cost reduction due to fewer RBC
      units transfused, the pharmacy may see an increase in
      costs for agents used for preoperative and/or outpatient
      anemia management [eg, intravenous (IV) iron] or
      intraoperative hemostatic agents [eg, tranexamic acid
      (TXA)]. When determining the budget for the program it is
      important to involve all affected areas, including
      laboratory services (blood bank, coagulation, and
      hematology), pharmacy, perioperative services, infusion
      center, and other relevant facility departments or
      services.

      Any new revenue that is generated also needs to be
      considered. For example, outpatient anemia management
      efforts may add new revenue (from new infusion and
      injection procedures) in addition to new costs associated
      with the procedure and medications. New tests may add
      new revenue. The objective is to determine the total
      financial impact of the PBM program as follows:

      – $$$$ cost of program (this is the budget)
      + $$$$ savings from blood not given
      + $$$$ savings from transfusion procedures not done
      – $$$$ cost of other quality benefits (see above)
      + $$$$ new revenue (eg, outpatient anemia
      management)
      = Total financial impact

 5. Pre-transfusion patient testing and evaluation.                                X        X              X

Copyright: 2022 The Joint Commission   Patient Blood Management Review Process Guide       Page 36 of 66
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